A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  Increasing doses (3 mg/7 mg/14 mg) of semaglutide tablets to be taken with water at the same time every morning in a fasting state
• Placebo (semaglutide) — DRUG
  Placebo tablets to be taken with water at the same time every morning in a fasting state

Study Details

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

Key Dates

Start date

Jun 17, 2019

Status verified

Nov 2025

Primary completion

Aug 23, 2024

Completion

Aug 23, 2024

Study Design

Enrollment

9,651 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Oral semaglutide
  One tablet daily for 3.5 to 5 years
• Placebo Comparator: Placebo
  One tablet daily for 3.5 to 5 years

Primary Outcome Measure

Number of Participants From Randomization to First Occurrence of a Major Adverse Cardiovascular Event (MACE), a Composite Endpoint Consisting of: Cardiovascular (CV) Death/Non-fatal Myocardial Infarction/Non-fatal Stroke [ Time Frame: From randomisation (week 0) up to week 265 ]

Locations (91)

Related coverage on Hipa.ai

• Oral Semaglutide Reduces Major Adverse CV Events in Type 2 Diabetes
  Semaglutide · Sep 22, 2025 · ClinicalTrials.gov

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